The device was not returned to olympus medical systems corp.(omsc), but returned to olympus repair center for the evaluation.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
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This supplemental report is being submitted to provide additional information.The device in this report has not been returned to olympus medical systems corp.(omsc), therefore omsc could not confirm the device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The instruction manual provides preventive measures against the reported failure mode.The exact cause of the reported event could not be conclusively determined.Omsc was informed that there was a sign of liquid intrusion at the pipeline of the device.Omsc surmised that this phenomenon attributed to the backflow of the liquid into the device.If significant additional information is received, this report will be supplemented.
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This supplemental report is to inform that upon further review, per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Initially, we determined that the event was mdr reportable due to a backflow of liquid from the water container into the unit co2 regulator (ucr), in which case we determined that it was a potential adverse event because of the risk for infection.Upon further investigation, it was found that liquid does not flow back into the ucr from the water container unless multiple situations occur simultaneously.There are no reports of situations occurring for this complaint.In addition, a component analysis was performed on the water droplet traces in the tube of the ucr at a similar complaint.The results of this component analysis detected silica and others that appeared to be derived from tap water, but no component that appeared to be body fluids were detected.
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